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Ke Li
Declaration
I certify that this dissertation does not incorporate any material previously submitted for a
degree or diploma from any university. To the best of my knowledge, this dissertation
does not contain any material previously published or written by another person, without
acknowledgement, and where due reference has not been made in the text. I alone are the
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Abstract
Thesis Title: A pilot study to evaluate the effect of acupuncture on increasing milk
Breastfeeding benefits the mother as well as the baby. Breast milk is a complete food for
newborn human infants, adequately supplying all nutritional needs for at least the first 4-
6 months of life (Kramer & Kakuma, 2002). In 1993, the Commonwealth of Australia
recommended the following goals for promoting breastfeeding by the year 2000 and
beyond (Nutbeam, Wise, Bauman, Harris & Leader, 1993): For infants to the age of three
months, 60% should be fully breastfed or 80% should be partially breastfed. For infants
to the age of six months, 50% should be fully breastfed or 80% should be partially
breastfed. However, according to the most recent national survey, these targets have not
been met (Donath, 2000). In effect, breastfeeding figures have not changed in the last ten
Research indicates that the largest decrease in breastfeeding occurs between two weeks
and six weeks after birth (Binns & Scotts, 2002; Stamp & Crowther, 1995; Mogan 1986),
with women giving Insufficient Milk Supply (IMS) as the major reason for stopping.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
However, failure to thrive in infancy can be seen in babies who do not achieve an
adequate weight gain within the normal time span. According to lactation consultants at
babies who are breastfed present with inadequate weight gain due to IMS. Women with
low breastmilk supply who wish to persist with breastfeeding often look for some means
to increase their milk supply. There are very few alternative treatment to assist them.
For over a thousand years mothers in China have used acupuncture to increase their
supply of breast milk. Within the last decade, several authors have published results of
studies on the effect of Traditional Chinese Acupuncture (TCA) on lactation (Wu, 2002;
Huang & Huang, 1994; Tureanu, 1994; Dong, 1988; Kang, 1990). These study all
indicated improvement in lactation after TCA therapy. However, all these studies have
This research is a first single blind controlled clinical trial to investigate the effectiveness
of Traditional Chinese Acupuncture for the treatment of IMS. The aim of the study is to
find out whether a course of Traditional Chinese Acupuncture treatment would help
mothers diagnosed with insufficient breast milk supply produce more milk.
completing the five years program at the Beijing College of TCM in China. The
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
This is a pilot study. The final number of subjects in the study was 27,: 9 in the
Traditional Chinese Acupuncture (TCA) Group; 6 in the Sham Acupuncture (SA) Group
and 12 in the Non-Treatment Control Group. The major finding of the study was that -
"Other things being equal, infants whose mothers received TCA weighed 160.13 grams
more on average than those whose mothers received SA. This effect is marginally
significant (p<0.1)". The finding generally confirms that the Traditional Chinese
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Acknowledgments
I am most grateful to Dr Kerry Watson and Associate Professor Jill Teschendorff, if not
for their continued support, advice and guidance, this research would never have been
completed.
I would like to thank Professor Sheng Yang Guo, a statistician of the University of
Tennessee, United States. In this research the results was revealed nothing of
significance when using the traditional repeated measures, MANOVA. However, on the
advice of Professor Guo and taking advantage of his great knowledge of statistics, we
applied Hierarchical linear modelling method (HLM), and found that the study produced
I would like to thank Ms Heather Harris the Lactation consultant in the Breastfeeding
Assessment Service at the Royal Women’s Hospital, for her support and the invaluable
advice on breastfeeding she provided. At the same time I would also like to thank other
I would like thank to Ms Janice Edwards for her professional advice on breastfeeding as
well as the Royal Women’s Hospital in Melbourne and Sunshine Hospital in Melbourne.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
I would also like to thank all the mothers who participated in the treatment groups.
Without them, of course, the study would not have been possible.
I would like to thank Acu-Needs for their support study grant. Finally, I would like to
thank Teena Zhang my daughter. She always managed to read my drafts and share my
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
TABLE OF CONTENTS
DECLARATION………...………………………………………………i
ABSTRACT..……………..…………………………………………….ii
ACKNOWLEDGMENTS….…...….…………………………………..v
TABLE OF CONTENTS….……………………………………………1
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
CHAPTER 7. CONCLUSION...............................................................69
REFERENCE..........................................................................................98
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Chapter 1: Introduction
1.1 Introduction
Breastmilk is a complete food for full term infants, adequately supplying all
nutritional needs for at least the first six months of life (Butte, Lopez-Alarcon , Garza
for promoting breastfeeding by the year 2000 and beyond (Nutbeam, et al, 1993.):
For infants to the age of three months, 60% should be fully breastfed or 80% should
be partially breastfed. For infants to the age of six months, 50% should be fully
breastfed or 80% should be partially breastfed. However, according to the most recent
national survey, these targets have not been met. In effect, breastfeeding figures have
not changed in the last ten to fifteen years (Donath , Amir, 2000; Mortensen, 2001).
Research indicates that the largest decrease in breastfeeding occurs between two
weeks and six weeks after birth with women giving Insufficient Milk Supply (IMS) as
the major reason for stopping. Many authors suggested the most common causes of
IMS are poor breastfeeding management practices and maternal anxiety. The mother
believes that her milk supply is inadequate and becomes anxious, which in itself can
exacerbate IMS (Binns , Scott, 2002; Stamp , Crowther, 1995; NHMRC 1994; Mogan,
1986),
However, failure to thrive in infancy can be seen in babies who do not achieve an
adequate weight gain within the normal time span. According to lactation consultants
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
some babies who are breastfed present with inadequate weight gain due to IMS. a.
Women with low breastmilk supply who wish to persist with breastfeeding often look
for some means to increase their milk supply. There are very few alternative
For over a thousand years mothers in China have used acupuncture to increase their
supply of breast milk. Within the last decade, several authors have published results
(Wu, 2002; Huang & Huang, 1994; Tureanu, 1994; Dong, 1988; Kang, 1990). These
studies all indicated improvement in lactation after TCA therapy. However, all these
studies have been uncontrolled clinical trials. For credible clinical evaluation, a
This research is the first single blind controlled clinical trial to investigate the
effectiveness of Traditional Chinese Acupuncture for the treatment of IMS. The aim
of the study was to find out whether a course of Traditional Chinese Acupuncture
treatment would help mothers diagnosed with IMS to produce more milk.
This clinical trial was conducted by the author who is a qualified and registered
of Medicine degree in TCM after completing the five years program at the Beijing
College of TCM in China. The researcher has been in clinical practice for more than
15 years.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
This was a pilot study. The final number of subjects in the study was twenty-seven.
Nine were in the Traditional Chinese Acupuncture (TCA) Group, Six were in the
Sham Acupuncture (SA) Group and twelve were in the Non-Treatment Control (NTC)
Group. Because more in-depth data was collected from the TCA and the SA Groups
than the NTC Group, the multivariate analysis was only performed for the TCA and
SA Groups. The major finding of the study was that "other things being equal, after
the two week treatment period, infants whose mothers received TCA weighed 160.13
grams more on average than those whose mothers received SA. This effect is
marginally significant (p<0.1). The finding generally confirms that the Traditional
weight gain. The study also raises many issues with regard to conducting clinical
trials in this area. These issues are discussed in chapter six of the thesis.
be a function of the smooth flow of qi, through a series of pathways called meridians
and collaterals which link all parts of the body into a single integrated whole. Disease
p.164)
Xue: Xue translates as blood and its functions. In TCM, blood is formed from
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
and insufficient breastmilk supply (IMS) both in concurrent therapies and Chinese
how much breastmilk that a lactating mother has made while she is feeding her child
on her breast. And there is lack strategies no booth up mother’s breastmilk production
without side effects. Chinese medicine has long history to treat this complaint.
In chapter 3 contains the aim and objectives of the study. The aim of the study is to
who had been diagnosed by lactation consultant with insufficient breastmilk supply
could increase the breastmilk production. There are also few objects in the study.
There are: to review the contemporary literature with respect to IMS; to review the
classical and contemporary TCM literature pertaining to IMS; to design and conduct a
single blind controlled clinical trial to assess and determine the effectiveness of TCA
performed on nursing mothers who experience IMS, increases their infant’s weight
nursing mothers who experience IMS, reduces their infant’s consumption of formula.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
In chapter 4 is the methodology and techniques used in the study. The study is a
single blind randomised controlled clinical trial. In this chapter, research explained
how was subjects randomised and how was clinical intervention performed.
In chapter 5 results and findings has contents the method used in analysis date.
Hierarchical Linear Modeling (HLM) was the primary statistical model employed in
the evaluation. The study has found that: Other things being equal, an infant from
TCA Group weighs 160.13 grams heavier than his/her SA Group counterpart. This
effect is marginally significant (p<0.1). The finding generally confirms that the
Chapter 6 has discussed many funding and problems occurred during the study based
on the discussions and made regerminations for future studies in this field.
Over all discussions chapter 7 has finalised conclusion that this study has conformed
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Breast milk is a complete food for newborn human infants, adequately supplying all
nutritional needs for at least the first six months of life. Based on studies, researches
have stated that: the longer the duration of breastfeeding the better for the baby
Breastfeeding protects against illness and infection in infants and children. Breastfed
babies have less diarrhoea, respiratory tract infections, and ear infections. Chantry of
survey of 2277 children aged six to 24 months. After looking at rates of pneumonia,
wheezing, and recurrent colds and ear infections, infants fully breastfed for six
months had a fivefold reduced risk of pneumonia during the first two years, and a
twofold reduced risk of recurring ear infections. In Third World Countries, the early
introduction of breastfeeding reduces the death rate by at least five times (Oddy, 2002;
Oddy, 2001; Victora , Barros, 2000; César, 1999; Duncan, Holberg, Wright, Martinez,
Breastfed babies have less allergies, asthma, celiac disease and neonatal necrotizing
enterocolitis (Oddy, 1999; Oddy, 2000; Falth-Magnussonl, 1996; Lucas , Cole, 1990).
Breastfed babies also have less incidence of Sudden Infant Death Syndrome and less
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
cardiovascular disease. Breastfed babies have better teeth than bottlefed babies and
have less visits to health care services and less hospital admissions. Diseases such as
cholera have never been reported among exclusively breastfeeding infants (Kramer ,
Kakuma, 2002; Comb , Marino, 1993; Mitchell, Taylor, Ford, Stewart, Becroft ,
Thompson, 1992).
Breastfeeding for the mothers is usually both pleasurable and convenient. Exclusive
breastfeeding could also give most mothers effective fertility control for at least three
months. Breastfeeding could reduce the risk of breast cancer. Breastfeeding is much
cheaper than formula feeding, reduces medical bills and enhance postpartum weight
loss for the mothers. Breastfeeding is also environmental friendly (Speller, 2000;
Hollander, 1997; Pugh, Milligan, Frick, Spatz , Bronner, 2002; Ball , Wright, 1999;
The Wold Health Organization states that: “Virtually all women can lactate; genuine
physiopathological reasons for not being able to breastfeed are rare” (WHO /
UNICEF; 1989, p 7). With that said, many women worldwide do not persist with
• For infants to age of three months, 60% should be fully breastfed or 80% should
be partially breastfed.
• For infants to age of six months, 50% should be fully breastfed or 80% should be
partially breastfed.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
However, according to the most recent national survey, there are 81.8 % of women
fully breastfeeding on discharge and only 57.1% still breastfeeding after three months
and this figure hasn't changed in the last fifteen years. (Donath & Amir, 2000;
Mortensen, 2001).
Previous researchers have sought to delineate factors that correlate with the duration
status, is married, and is older. In addition she is less likely to smoke, she is likely to
have attended prenatal classes and to have previously breastfed. She is also likely to
have had a normal singleton birth, and a healthy baby. She nurses the infant shortly
after birth, the infant rooms-in with the mother and is fed on demand. Another factor
which contributes to successful breastfeeding is the presence of nursing staff who are
role in helping women to breastfeed their infants. Finally the partner, family and
social support are also significant in this regard (WHO, 1998; Donath & Amir, , 2002;
Virginia, Combs, Marino, 1993; Clark , Beal, 1982; Ellis, 1984; Winikoff, 1986;
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Indicators for less successful breastfeeding experiences are a long and difficult labour;
indicates that mothers who are from aboriginal communities, ethnic groups or who are
immigrants are less likely to breastfeed their infant for long periods of time (Eades,
2000; Diong, Johnson and Langdon, 2000; Rossiter, 1994 and 1992).
Studies indicate that the period between birth and 6 weeks after birth is a critical time
for breastfeeding. During that period, women give “insufficient milk supply” as the
most common reason for stopping breastfeeding early. Around 50% of breastfeeding
women felt they had insufficient milk supply at some stage (Binns, 2002; Eades 2000;
study conducted in 1993, 80% of the women in the study perceived that they had
Insufficient milk supply is defined as a state in which a mother has or perceives that
she has inadequate milk to satisfy her infant’s hunger and thus, to support the infant’s
adequate weight gain (Hill , Humenick, 1989). Many researchers and authors have
suggested that the most common causes of IMS are poor breastfeeding management
practices. This can be the result of a delay in the first feed; a rigid and/or infrequent
feeding schedule, the infant having poor positioning and attachment on the breast,
Lawrence, 1999; Moulden, 1994). However, perhaps the most significant of the many
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
factors blamed for IMS is maternal anxiety (WHO, 1998). Anxiety of the mother
could suppress the excretion of prolactin and oxytocin. Also if the mother believes
that her milk supply is inadequate and becomes anxious, which in itself can
problem (McIntyre, 1995). Less than one paragraph is devoted to IMS in a text
However, there are many maternal factors associated with IMS that should not be
dismissed. They include: insufficient glandular tissue in the breast, breast surgery,
breast cancer, the mother being severely undernourished or carrying excess body
weight, the mother being on some pharmacological drugs, consumption of alcohol and
smoking. Other factors include hormonal imbalance in the mother such as low levels
of progesterone, prolactin, oxytocin and thyroid hormones, maternal stress and fatigue
(Lawrence & Lawrence, 1999; Clements, 2002; Donath, 2000; Rutishauser , Carlin,
1992).
The problem in diagnosing IMS is that there is no clear way to measure how much
breast milk is produced on a daily basis. Daly and Hartmann (1995) developed the
Computerized Breast Measurement system (CBM system) in 1992. This system has
allowed for the measurement of the short-term (between breastfeeds) rates of milk
synthesis in women. However, the machine is very costly and so far it has not been
used clinically. The measurement of the maternal urinary lactose excretion has been
breastmilk output have a positive association. This could provide a low cost and non-
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
urinary lactose is also affected by maternal diet (Kalwarf , Kalis, 1997; Murtaugh,
Another method is the test weighing procedure. This procedure involves weighing the
infant before and after each feed for 24 hours. This testing method indicates the
infant's breast milk intake and the mother's milk production. However, fluid loss by
evaporation will alter the total quantity of breastmilk intake by the infant (Rattigan,
1981). Another concern with the procedure is that test-weighing after each feed can
cause enormous stress in the mother. This method is very unpopular among lactation
consultants. Therefore the National Health and Medical Research Council (NHMRC,
1985) has given guidelines on the procedure. The guidelines point out that:
be aware of the normal variation which exists between in infants and nursing
potential adverse affects this may have on the mother (frequency of weighing
should occur no more than is required to determine that the infant is growing
satisfactorily)”.
change with age. However, initially after birth, the normal infant loses 5% -10% of
their body weight before starting to gain weight. After two weeks they should have
returned to their birth weight. Most infants regain their birth weight by the eighth
day. An exclusively breastfed infant will regain their birth weight quicker than a
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
formula fed infant. The recommended weight for age 0-3 months is 26-31grams per
day and from 3-6 months of age, it is 17-18 grams per day (NHMRC, 1994; Lawrence
& Lawrence,1999, pp398). In Wells’ study has indicated that children's growth is
highly plastic during their infancy. In this period, many environmental factors
interfere with the infant’s growth. However infant nutrition has been shown to be the
The term 'failure to thrive' has been loosely described as an infant who shows some
degree of growth failure. The most common definition is when the infant continues to
lose weight after 10 days of age, or gains at a rate below the tenth percentile for
weight gain for that age (Lawrence & Lawrence, 1999, p398).
However, many breastfeeding health care workers and some authors have observed
that the infant seems to stop growing in either weight or length, with no sign of illness
in during certain periods. Then at other times the infant might grow faster than usual.
This phenomenon has been called "growth spurt" or "catch up growth" and “catch
down growth” (Cox, 1997; Marcovitch, 1994). Lampl, Veldhuis and Johnson (1992)
published the results of a study on healthy infant growth. The researchers made serial
measurements of normal infants during the infant’s first 21 months. The measurement
was on weekly, semiweekly, and daily basis. They showed clearly that growth in
were 0.5 to 2.5 centimeters during intervals separated by no measurable change from
2 to 63 days duration. There have been no definitive studies on how to predict the
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
babies who are breastfed, do not receive an adequate milk supply. This problem is
identified when babies do not achieve an adequate weight gain within the normal time
span, e.g. a baby under four months of age does not gain 140 grams per week for two
consecutive weeks. However weight is not the only indication to consider when
ascertaining if the mother isn't producing sufficient breastmilk. There are other factors
such as if an infant has used formulas regularly to supplement breastmilk. Even if the
infant has achieved adequate weight gain, there may still be indicators that the mother
hasn't produced enough breast milk to meet the infant's demand. In the two
breastfeeding history, examine the mother's nipples and infant's health status and
observe two breast feeds over a period of four hours. At the same time the lactation
consultants check the infant's attachment to the breast, sucking technique and how the
mother is positioning the infant to the breast. At the end of each feed, an electrical
pump is used to express any remaining milk. A diagnosis of low supply may then be
made.
the problems of low breastfeeding rates amongst mothers. A study by Rossiter (1994)
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
an education program about breastfeeding and its benefits, whereas the control group
received only pamphlets on breastfeeding during their initial visit to the antenatal
clinic. Findings showed that mothers in the experimental group had a more positive
attitude to breastfeeding than those in the control group in that they indicated an
intention to breastfeed their infant at birth and at four weeks of age. However, there
breastfeeding six months postpartum. Few other researches have indicated similar
Women with IMS who wish to persist with breastfeeding often look for some means
56.9% of women with IMS were using Metoclopramide to increase the milk supply.
The reason given was “when all else has failed to increase supply ” (McIntyre, 1995,
p. 80).
more than two thousand years (Zhang 1990 pp3-5). TCM describes the universe as
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
one whole dynamic system within which all things are interrelated. The person is
seen as a microcosm of the universe in which every aspect of the person and their
within the person and between the person and their environment. Illness is described
(1983,pp.258-259):
“Chinese medicine [TCM] offers a different vision of health and disease, one
to see the individual as an entity separate from his or her environment. Most
aims to cure through treatments that encompass the whole of the individual as
closely.
This therapy has developed over five thousand years. Acupuncture is the procedure of
treatment for a variety of common health problems. These specific areas are called
acupuncture points. They lay along the specific lines of the body. These lines are
The meridians and collaterals system is a most important concept in TCM. The place
of the meridians and collaterals system in TCM is akin to anatomy and physiology in
biomedicine. TCM uses the meridians/collaterals system to explain both structure and
function. The meridians and collaterals are energetic pathways linking inner organs
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
and various points on the surface of the body. They distribute qi, xue (blood) and jin
ye (body fluids) around the body therefore nourishing the organs and tissues. The
flow of the qi and xue (blood) should be constant and smooth. If this order has been
disturbed, an imbalance will occur and illness will result (Watson 1991).
In the last two decades, acupuncture treatment has flourished around the world. There
has been extensive research into the physiological and biochemical bases of
acupuncture, Those researchers have found that needling the acupuncture points, helps
to stimulate the nervous and endocrine systems to release chemicals in the body which
influence the body's own internal regulating system (Li P, Huang Y, Xu W, Chen G
and Li X, 2002; Liu Z, Deng H and Liu H 2002). However, no research has
The Chinese have had long history in treating breastfeeding problems dating back to
the Han dynasty (221BC – 220). At the time, the Chinese called the doctor who
doctor’ or the ‘breast's doctor’. This meant that they focussed on women's health,
birthing and breast feeding (Ma, 1994 p3). In comparing today's general
breastfeeding advice and that of ancient China, the theory and practice of
breastfeeding have not changed. Advice given in ancient Chinese texts sounds
remarkably similar to the advice we would give today to a mother who has just
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
delivered a child. As early as the middle of the 7th century, Sun Si Miao wrote in his
Bei Ji Qian Jian Yao Fang (in Jiang , Zhang1995 p33) that the child should be fed on
demand. In a 12th century Chinese text - Huo You Kuo Yi (Yan 1115-1368AC in
Jiang ,Zhang, 1995 p34) stated that breastfeeding should start soon after birth. The
author also points out that breastfeeding should continue until the baby is two to three
years of age. In the early 17th century, Gang Ting Jian in his work "Shuo Shi Bao
Yuan" (Gong early 17th century in Ni , Li, 1994, p493) stated that:“ milk should be the
only food for infants aged four to five months old. Light porridge should be added
only after 6 months of age. And food that is fatty or sweet and hard to digest, should
be gradually added only after one year of age”. All the above recommendations are
"When the child is in the womb, the highway tracts move xue (blood) to raise it.
When the child is born, the highway tracts carry xue (blood) in order to produce
Stone , Stone, 1994 p533)."The function of xue (blood) is to nourish, moisten and
warm the body. Xue (blood) supports the functioning of both body and mind,
however, only if the xue is circulating (Zhang, 1990 p185). Breastmilk and xue
(blood) have the same origin. Therefore, breastmilk has similar functions and
properties as xue (blood). From a TCM perspective, the mother’s diet and emotions
interfere with the nature of breastmilk. If the mother avoids fatty, spicy foods and
keeps her mind peaceful, the nature of her breastmilk will be come cooler and lighter.
Her breastmilk would be the most suitable food for the infant’s immature yang
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
constitution, weaker wei (stomach meridian) and pi (spleen meridian) systems (Li Shi
The breast and the meridians/collaterals: From a TCM perspective, the wei
(stomach) meridian run through the breast. The stomach meridian is said to be the sea
of water and grains (fluids and food). The production of xue (blood) is controlled by
the wei (stomach meridian system) and the pi (spleen meridian system). After women
give birth, xue (blood) is directed to the breast via the ‘highway track’ (meridians and
xue (blood) vessels) to produce milk to feed the infant. The highway track is part of
Chong Mai (penetrating vessel) and Ren Mai (conception vessel). If the qi and xue
(blood) of Chong Mai, Ren Mai together with the wei (stomach meridian system) and
the pi (spleen meridian system) are strong the breasts will produce plenty of high
quality milk.
In TCM, the nipple is linked with the gan (liver) meridian. Breastmilk release relies
on the smooth movement of gan (liver) qi. If the gan (liver) qi is not flowing freely, it
will effect the flow of milk from the breast. If the milk is not removed efficiently, the
high way track of the Chong Mai and the Ren Mai will become blocked. Blood will
then move back into the uterus. If that happens, menstruation occurs and breast milk
production is reduced (Xue Yi, 1486 –1558 in Gu and Tang, 1992 p35 , P36; Ma,
1994).
The use of acupuncture to increase insufficient milk supply has a long history in
China. The earliest reference to it was recorded more than a thousand years ago
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
(Huang Fumi, 282, BC). Insufficient milk supply is due to two clinical disharmonies:
treatment strategies. There are various clinical signs and symptoms that differentiate
The following signs and symptoms are associated with pi (spleen) qi xu (deficiency):
• lassitude;
• shortness of breath
• spontaneous sweating;
• paleness of complexion;
• a pale tongue;
and
• an empty pulse quality (if qi xu has lead to xue (blood) xu, the pulse
will be thready)
The above symptoms are aggravated by physical activity. This pattern is usually due
• belching;
and
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
promote milk production and the let-down of milk, as well as inducing relaxation and
recuperation after the pregnancy and birth. For the condition of pi (spleen) qi
deficiency, the principle of treatment is to tonify qi. For the condition of gan (liver) qi
In the last two decades, several authors have published results of studies on the effect
of TCA on lactation. Each study used post feeding infant crying frequency as the
measurement of a lack of breast milk production. Tureanu had treated 27 subjects who
presented with insufficient breastmilk supply. In this study, Tureanu’s used a suckling
test (weight of the infant before and after each nursing session and the newborn’s
growth curve). These studies all indicated improvement in lactation after TCA
therapy. Dong’s study utilised a sample of 414 women with IMS. All of the women
were able to breastfed fully after the course of acupuncture treatment. Huang’s study
involved an extensive sample of women with IMS (1,643 subjects), 98.4% responding
with Chinese herbal medicine treatment. However, each of these studies only had an
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
experimental group and no control group (Tureanu, 1994; Dong, 1988; Huang 1994,
Wu, 2002). For credible clinical evaluation, an appropriate control group is essential
(Watson, 1991).
Breast milk is the recommended food for human infants for at least the first six
months of life (Kramer ,Kakuma, 2002). “Insufficient milk supply” is the most
common reason for the early cessation of breastfeeding (Binns 2002, Hill, 1991;
Mogan, 1986). IMS has been defined as a state in which a mother has or perceives
that she has inadequate milk supply to satisfy her infant’s hunger and thus, to support
Numerous causes have been suggested for IMS from poor breastfeeding technique
(McIntyre, 1995) to lack of oxytocin (Ueda T., Yokoyama Y., Irahara M & Aono T.,
1994). At present there is no proven therapy to overcome IMS that does not result in
adverse side-effects. For over a thousand years acupuncture has been used to promote
breast-milk supply. In recent years, there have been many TCA clinical trials on IMS.
All these studies have been uncontrolled.. For credible clinical evaluation, an
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
3.1 Aim
3.2 Objectives
• To design and conduct a single blind controlled clinical trial to assess and
nursing mothers who experience IMS, increases their infant’s weight gain.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
This study is a single blind controlled clinical trial. Mothers who had been identified
The study was undertaken at the Breastfeeding Assessment Service (BFAS) of the
(BFS) at Sunshine Hospital, Sunshine, Victoria, Australia. These two hospitals are
both part of the Women’s and Children’s Health Care Network. Both hospitals
Ethical approval was obtained from both Victoria University & the hospitals involved
The subjects came from the central or north western metropolitan area of Melbourne.
They were selected by the lactation consultants at the BFAS of Royal Women's
Hospital and the BFS of Sunshine Hospital. The selection criteria for the subjects
were as follows:
• the infant was breastfed or receiving expressed breast milk from the mother.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
• the infant had not recently achieved adequate weight gain - that is had gained less
than 140g per week for at least two consecutive weeks, or a newborn infant,
younger than two weeks old who has not regained their birth weight in 12 days, or
gain.
• the baby was not suffering from any other medical conditions,
• the lactation consultants at BFAS or BFS had diagnosed the reason for low weight
Lactation consultants at the BFAS and BFS introduced the study to the mothers
identified as experiencing IMS. If the mother agreed to participate in the study, she
was referred to the researcher. Lactation consultants were given copies of the study
protocol to ensure that the same procedure was followed by each of them (Appendix 2
4.3 Intervention
Forty- one mothers who had been identified as not producing enough breast milk were
referred to the researcher. All the mothers received a copy of the Participant
ensure that everyone fully understood the procedures of the study. All the mothers
read through the consent form with the researcher or lactation consultant who was
involved the study and signed the consent form (Appendix 4).
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Initially, all the mothers were asked to choose whether they wished to have
acupuncture or not. Those who chose not to have acupuncture became the Non-
Treatment Control (NTC) Group. Those mothers in the NTC Group continued to
Subjects who chose to receive acupuncture were assessed in accordance with TCM
“When making a diagnosis in TCM, the practitioner not only considers the
generic signs and symptoms of a pathology but also the signs and symptoms
Subjects who were prepared to have acupuncture were examined by the researcher
Listening: to the sound of the subject's speaking voice , breath, cough etc.
relationships etc,
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Two major patterns of disharmony were identified in the subjects. These were pi
according to these two patterns of disharmony and then randomized into two groups:
i) the experimental group - the Traditional Chinese Acupuncture Group (TCA Group),
where the subjects were given acupuncture therapy in accordance with TCM
as required;
ii) the active control group - the Sham Acupuncture Group (SA Group), where the
Acupuncture therapy commenced as soon as possible after the initial contact with the
researcher. The therapy was administered three times per week for two weeks at the
participating hospitals. The treatments used on each paired TCA and SA subjects were
as similar as possible. As the points needled changed on the subjects receiving TCA at
various times during the study, the areas needled on those receiving SA were also
changed. The areas needled on those in the SA Group were in the same anatomical
area as the points needled on the subjects in the TCA group (discussing detail on the
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
The same number of insertions were used for subjects in both groups and any needle
techniques used on subjects receiving TCA were duplicated on the paired subjects
receiving SA. The lactation consultants were unaware of the group to which each
clients belonged.
All mothers in the study were initially assessed and had their details recorded by the
lactation consultant involved in the study (see Appendix 5 Consultation Record). All
subjects in the study had been given a two week feeding dairy (Appendix 6). They
were asked to record the time of each feed, the time of expressing breastmilk and the
quantity of breastmilk being collected, the time and quantity of formula been used,
Mothers in the treatment groups were further assessed by the researcher according to
TCM the framework, and had their details recorded by the researcher. Infants in the
TCA and SA Groups were weighed each time their mother received acupuncture
treatment. Same scale was used during the study. If solid foods were introduced
during the two weeks of the treatment period, the baby was counted as not responding
to the treatment and was no longer included in the trial. The Non-Treatment Control
(NTC) Group were monitored and followed up after two weeks re their diaries. They
were asked to return to the hospital so their infant could be weighed. They were also
For insufficient milk supply, the basic acupuncture points used in this study were::
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Ren18 (Tanzhong), midway between two nipples. The sham point matches for
Ren.17 was 3 cun above from Ren17 and 0.5 cun lateral to the midline.
St.18 (Rugeng), below the nipple, in the 5th intercostal space. The sham point
matches for St.17 was 3 cun down from St.17 and 4.5 cun lateral to the
midline.
A subject who had the condition of pi (spleen) xu (deficiency) of Qi, will received the
B20 (Pishu), 1.5 cun lateral to the lower border of the spinous process of the
11th thoracic vertebra. The sham point match for B20 (Pishu), was 3 cun down
from B20, 2 cun lateral to the lower border of the spinous process.
St.36 (Zusanli), 3 cun below the patella and lateral to the patellar ligament one
finger breadth from the anterior crest of the tibia. The sham point matches for
St.36 (Zusanli), was 7 cun above St.36, 3 cun lateral to the thigh.
A subject who had the condition of Qi Stagnancy gan (liver) qi stagnation, will
Liv.3 (Taichong), On the dorsum of the foot, in the depression distal to the
junction of the 1st and 2nd metatarsal bones. The sham point match for Liv.3
(Taichong), was1 cun above Liv.3, 0.5 laterale from Liver Meridian.
Si.1 (Shaoze), on the ulnar side of the little finger, about 0.1 cun posterior to
the corner of the nail. The sham point match for Si.1 was on the ulnar side of
the middle finger, about 0.1 cm posterior to the corner of the nail.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
The same style, brand and size needles were used for both the TAC group and the SA
group, and the same needling techniques (skin preparation, needle manipulation etc.)
Brand Hwato
* Form of manipulation are including (1) reinforcing and reducing by twirling and
rotating the needle, (2) lifting and thrusting & (3) keeping the hole open or close.
Hygiene practices were in accordance with the Infection Control Guidelines for
Acupuncture (AACA, 1997). They will include only sterile disposable acupuncture
As mothers are likely to suffer from anxiety due to their infant’s inadequate weight
gain. All mothers continued to receive support from the lactation consultants as
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
After the first two weeks dairy keeping phase, the researcher telephoned the subjects
each month . Each month for six months, the researcher telephoned the mother to
ascertain the status of breastfeeding and the infant’s current weight (weight was
measured and therefore compared on the same scale each time). (weight would be
measured on their scale). The infants weight gain stopped being recorded if they had
been introduced to solids. within the six months. The follow up was discontinued if
the infant had been weaned within the six months of following phase.
Participation in this study was voluntary and informed consent was will be obtained
from all subjects (see Appendix 6 - Copy of Consent Forms). The confidentiality and
anonymity of the research files was maintained. Only the researcher and the
Data was recorded by hand while interviewing the subjects (mothers) and then
transferred onto disk as a Micosoft Word document. All data was locked away
securely. No other person, other than the researcher was able to access the data.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Forty-one women agreed to participate in the study. Their infants were aged between
12 and 133 days when they entered the study. There were ten subjects in the
Traditional Chinese Acupuncture (TCA) Group. Nine of them completed the two
weeks of treatment. One subject withdrew from the study after the first treatment
when she discovered she had received a parking fine when attending the hospital to
There were seven subjects in the Sham Acupuncture (SA) Group. One of them
withdrew from the study after the third treatment. She gave no explanation for her
withdrawal.
There were twenty-four subjects in the Non-Treatment Control (NTC) Group. Twelve
subjects withdrew from the study during the initial two weeks dairy keeping phase.
One infant was admitted to hospital due to low weight gain, so its mother stopped
keeping the feeding record. Four babies were weaning during the two weeks period.
Five subjects did not respond to the researcher’s phone calls. One subject withdrew
from the study because she found keeping the diary difficult. One subject withdrew
because she disagreed with the diagnosis given by the Lactation Consultant.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
There were twenty-seven subjects (mother and babies pairs) included in the analysis:
nine in the TCA Group or 33%; six in the SA Group or 22% and twelve in the Non-
Treatment Control Group or 44%. One mother who originally participated in the
study as a member of the SA Group was excluded from the analysis because her
infant was 133 days old when entered into the study whereas the average age for the
rest of babies in the SA Group was thirty -eight days. Because more in-depth data
was collected from the TCA and the SA Groups than the Non-Treatment Control
Group, the multivariate analysis was only performed for the TCA and SA Groups.
The mean ages of the subjects (mothers) in the TCA Group was 32.44 years, 31.00
years in the SA Group and 31.50 in the NTC Group. There was no statistically
Hierarchical Linear Modeling (HLM) was the primary statistical model employed in
relationship between outcome and the predictor variables more from a dynamic
perspective;
(2) HLM does not require the time between assessments to be equivalent;
(3) HLM can include attrition subjects (that is, subjects who do not have complete
(4) the effects of potentially confounding predictor variables can be controlled for,
and
(5) HLM can compare directly the effects of two independent variables in a
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Some of these advantages make the model a unique approach to the study, due to the
over time. To control for the formula consumption in the evaluation of weight
change, one must look into the relationship between formula consumption and weight
MANOVA. Attrition is another problem: some babies in the study had missing data
excluded those subjects from the analysis. As this is a pilot study with only a small
number of subjects, the study could ill-afford the loss of these subjects. As a final
example, infants from this study were all measured at the baseline (i.e., day 1) and the
endpoint (i.e., day 14). However, they might have been evaluated at either day 2 or
day 3 for the second observation, at either day 4 or day 5 for the third observation, and
so on so forth. This unequal time spacing presents estimation problems for the
traditional models.
Two outcome variables were analysed: infant weight gain was measured in grams at
seven time points during the two-week period (i.e., data were collected approximately
every other day), and infant formula consumption was measured in millilitres
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
(2) age of the infant the beginning of the study (measured in days);
(3) infant suckling measure at the beginning of the study: a 6-point scale with value 6
indicates the best suckling capacity and value 1 the worst suckling capacity;
infant's
(4) mother’s breast-feeding sensation measure at the beginning of the study: a 4-point
scale where value 4 indicates “empty sensation most time” (the worst) and value 1
(5) mother’s “feeling unwell” measure at the beginning of the study: a 4-point scale
with value 3 indicating the worst feeling and value 0 the best;
(6) mother’s appetite measure at beginning of the study: a 4-point scale with value 4
(8) mother’s use of herbal medication to stimulate breast milk at beginning of the
(9) mother’s use of nutritional supplements at the beginning of the study: use or non-
use.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
5.3 Results
Table 2 presents the sample descriptive statistics. Notice that the TCA Group was
comprised of primarily female babies (78%), but the SA Group was comprised of
primarily male babies (33% female babies). The Non-Treatment Control Group
shared a similar pattern in gender composition with the TCA Group (67% females).
The mean age at the starting point was 33.9 days for the TCA Group, 38 days for the
The mean values of weight and formula consumption at different time points shown
by Table 1 are plotted and presented in Figure 1. Clearly, babies in the SA Group on
average had a heavier weight than babies in the TCA Group, at all time points. The
weight for infants in the NTC Group was only collected at the starting point and
endpoint. It appears that the mean weights of the NTC Group at both time points are
similar to those of the TCA Group. Notice that this figure presents the mean
trajectories of weight change. The growth curves do not control for numerous factors
affecting weight. At a first glance, the mean trajectories show an opposite direction to
children of SA Group who weighed heavier. The multivariate analysis of HLM aims
to reveal a purer effect of the intervention, namely, after controlling for other factors,
do infants in the SA Group continue to weigh heavier than babies children of the TCA
Group?
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Clearly, the sample mean trajectories show that babies in the SA Group consumed the
highest level of formula, babies in the NTC Group were the second highest
consumers, and infants in the TCA Group consumed the least amount of formula
(Figure 1). At a first glance, this pattern is consistent with the research hypothesis.
The question remains: whether the difference in formula consumption among the
Table 3 presents the results of HLM analysis. The linear model of weight change
estimated by HLM has a good fit to data, as shown by the deviance statistic. In
predicted values to gauge the usefulness of the HLM model. As shown by Figure 2,
the model-predicted mean value is very close to the observed value at all time points.
This clearly shows that the HLM fits the data very well. Based on the model, we now
summarize the major findings of weight change. Similar to findings drawn from other
statistical models, statistical significance of a variable from HLM (i.e., a p-value less
than .01, .05, or .1) indicates that such effect is likely to hold true in the population
who shares the same characteristics with subjects of the sample. These significant
• Other things being equal, an infant from TCA Group weighs 160.13 grams
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
TCA intervention with caution. At any rate, the study does confirm the
infant weight.
• Over time, the study infants generally grow at a rate of 36.97 grams per
day (p<0.01).
• Other things being equal, boys weigh 737.98 grams heavier than girls
(p<0.01).
• Old infants grow faster. Other things being equal, one-day increase in the
• Infants consuming more formula weigh heavier. Other things being equal,
• Infants of mothers who sense the breasts being empty most of the time
weigh heavier. Other things being equal, one-unit increase in the 4-point
that infants of such mothers may consume more formula, because the
literature shows that infants consuming formula only weigh heavier than
• Infants of mothers who feel unwell at starting point weigh lighter. Other
things being equal, one-unit increase in the 4-point “feeling unwell” scale
• Infants of mothers who have a good appetite weigh heavier. Other things
being equal, one-unit increase in the 4-point appetite scale (i.e., a tendency
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
• Infant’s of mothers who take herbal medication for enhancing breast milk
weigh heavier. Other things being equal, infants of such mothers weigh
1229.98 grams heavier than those whose mothers do not use herbal
medication (p<0.01).
Unlike the weight model, the linear model of formula change did not fit the data well.
We have tested all possible models using the existing predictor variables and found
none of them led to a good fit to the data. This indicates that the determinants of
formula change are complicated and different from those affecting weight. The model
predictors, that is, time (or rate of change), gender and age. Figure 2 shows that at
most time points, the model-predicted mean values are not close to the observed mean
values. Evidently, the model only depicts a linear growth trend of formula change for
both groups, and is less robust to capturing the up-and-downs of the observed mean
trajectories.
Given the above findings, results of the HLM analysis for formula change are only
indicative. The model shows that infants in the TCA Group consume less formula
than the SA Group. Other things being equal, infants in the TCA Group consumed
276.52 millilitres less formula than infants of the SA Group. Since the model did not
fit the data well and important predictors of formula change were not included in the
analysis, future studies using more relevant predictors may change the results.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
inconclusive.
After the two weeks dairy keeping phases, the researcher followed up all subjects by
telephone interview monthly for six months. All mothers weighed their infants
according to the infant age. Many of them did not weigh their infant at monthly
interval. In the TCA Group there were two mothers who lost contact in the first month
follow up. One of them had previously told the researcher that she is going to
interstate after the study. Contact was lost with another mother in the third month
follow up phase. One mother introduced solid food to her infant at three months of
age. Three mothers introduced solid food to their infants at four months of age. One
mother introduced solid food to her infant at the infant at five months of age. One
mother weaned in infant at three months of age and one mother weaned her infant at
the 5 months of age. Two mothers continued breastfeeding their infants six months
The researcher lost contact with one mother in the SA Group in the first month of the
follow up phase. Two mothers weaned their infants at four months of age. One
mother weaned her infant 5 months of age. Two mothers introduced solid food at four
months of age and one mother continued breastfeeding the infant six months after the
study.
The researcher lost contact with two mothers in the NTC Group in the first month of
the follow up phase. Two mothers weaned their infants at two months of age. Three
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
mothers weaned their infants at three months of age. Four mothers introduced solid
food at four months of age. One mother introduced solid food at five months of age.
Four mothers continued breastfeeding their infant six months after the study.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
_______________________________________________________________________________________________________________
Treatment Group Sham Group Control Group
(n=9) (n=6) (n=12)
____________________ ___________ ___________ ____________________
Variable M SD M SD M SD
________________________________________ __________ __________ __________ __________ __________ __________
Weight (g.)
Baseline (Day 1) 3855.3 925.5 4082.3 797.4 3926.8 691.09
At observation point 2 (Day 2 or 3) 3953.6 927.1 4219.3 849.5
At observation point 3 (Day 4 or 5) 4021.6 924.2 4641.6 450.1
At observation point 4 (Day 7) 4332.9 898.7 4419.3 898.7
At observation point 5 (Day 9 or 10) 4207.9 966.2 4493.8 1012.5
At observation point 6 (Day 11 or 12) 4348.8 948.4 5065.8 313.6
At observation point 7 (Day 14) 4444.4 880.4 4676.4 1020.3 4444.2 704.89
_______________________________________________________________________________________________________________
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Weight
5500
5000
Weight (g.)
4500 Treatment
Sham
4000 Control
3500
3000
1 3 5 7 10 12 14
Day
Formula
700
600
500
Formula (ml.)
400 Treatment
Sham
300 Control
200
100
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Day
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
_______________________________________________________________________________________________________
Variable Outcome Weight Outcome Formula
__________________________________________________________ ____________________ ____________________
Fixed Effect
Intercept 3530.35 *** 303.0 **
Time (unit change per day) 36.97 *** 5.83
Group Treatment (Sham is the reference) 160.13 * -276.52 **
Gender: Female (male is the reference) -737.98 *** 24.18
Age at baseline 20.67 *** 4.08
Formula consumption in the same day 0.16 **
Suckling scale 1.11
Presence of illness (absence is the reference) -174.25
Mother's breast-feeding sensation 392.41 **
Mother's "feeling unwell" -107.62 ***
Mother's appetite -528.26 ***
Mother's depression (absence is the reference) -59.03
Mother's use of herbal medication (absence is the reference) 1229.98 ***
Mother's use of nutrition supplement (absence is the reference) -366.51
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Weight
5500
Treatment
Weight (g.)
4500 Observed
Sham Predicted
4000
Sham Observed
3500
3000
1 3 5 7 10 12 14
Day
Formula
700
600
500
Formula (ml.)
400
Treatment Predicted
300
Treatment Observed
200 Sham Predicted
100 Sham Observed
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Day
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
After an extensive literature review, the researcher visited a few Maternity and Child
Health Nurses (MCHN) who worked in a local maternity and child health center.
They overwhelmingly supported the research. One MCHN who worked in the
Northern region of Melbourne said to the researcher: "I have experienced lactation
failure myself. I did all l was taught from my professional training and this is also
what I tell my clients. In the end, I had to switch to formula. There is not enough
Following the inquiry with the MCHNs, the researcher and one of her supervisors
held a meeting with a lactation consultant who also lectures in lactation in Victoria
Acupuncture in the treatment of IMS in Melbourne. It was evident that this was
supported. Then the researcher and one of her supervisors held a meeting with the
Victorian Department of Human Services. This meeting further explored the necessity
and feasibility of conducting this clinical trial. Three maternal and child health experts
1. the subject should continue their treatment with a lactation consultant during
acupuncture treatment.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
standard diagnosis for IMS so far. The study should be based on real low breast milk
supply rather than just the mother's perception. Therefore, it was decided that the
Health Nurse.
Several ideas about the study setting were discussed during the meeting with the
recruitment of subjects from private lactation consultants, as they believed that private
recruiting from local maternity and child health centres, but this was also rejected.
The reason stated was that the local maternity and child health nurses are very busy.
Therefore the quality of the services might not meet the standards of the research
requirement. The suggestion was to set the research in a hospital where there are
lactation services. One of the hospitals recommended by the Department is the Royal
The Royal Women's Hospital is a 400 beds obstetric, gynaecological and neonatal
paediatric hospital. The hospital delivers more than 4000 infants annually. It is located
and infant health and is a major teaching hospital, educating Australia's medical
practitioners, nurses and allied health professionals. There are two divisions offering
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
special services for breastfeeding, the division of neonatal services and the division of
maternity services.
The division of neonatal service is the service looking after newborns who are sick.
Most of the patients are premature infants, and most of them have medical
complications. Therefore, the normal breast feeding process could not be established
on time. The mothers purely rely on expressing milk to maintain their milk
production. Most of them take drugs to facilitate breast milk production as well. Even
so, many of them develop IMS later on. There is no other therapy available which can
The researcher proposed to use subjects from the neonatal service. We wanted to
recruit this population as the sample group. The researcher would only need to ask the
mothers to record the amount of breast milk expressed over a two week period. The
experiment would compare the difference in the quantity of milk production between
Treatment Control Group. By doing it in this way, not only would the measurement of
breast milk production be easy to determine but also a solution for this disadvantaged
population might be found if the therapy was shown to be effective. However, the
neonatal service rejected the request. They thought the current research design (TCA ,
SA Groups) couldn't determine whether the milk production would be the result of the
The Breastfeeding Assessment Service at the RWH is a day service for mothers who
have difficulty breastfeeding. The infants of these mothers are usually full term,
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
healthy and under the age of four months. This service is under the Division of
were asked to stay in hospital for at least two feeds. Each session with the lactation
consultants lasts over four hours. During this time, the lactation consultant carefully
takes a breastfeeding history, examine the mother’s nipples, breasts, state of the infant
health, infant’s attachment to the breast, sucking technique and how the mother is
positioning the infant to the breast. Each lactation consultant sees a maximum of three
infanta and mother pairs in a shift of eight hours. On average one mother would make
four visits to BFAS. Lactation consultants spend a lot of time on the telephone
checking to make sure that the mother does know the breastfeeding technique.
If a breastfed infant has no identified organic disorder and gains less than 140g for
two consecutive weeks, then the BFAS considers that infant hasn't received enough
confirm that the mother hasn’t produced enough breastmilk. They will observe the
infant's behavior when he/she is off the breast, and ask the mother to express breast
milk by using an electrical breast pump. These diagnostics procedures were not used
as an entrance criteria into this study as they haven't been fully tested by scientific
research. The diagnostic approach was based on the experience of the lactation
consultants.
From the day the study was approved to the first subject participating in the study,
took 5 months. From the first subject to the last took two years. During this time the
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
invitations twice to all Victorian Maternal and Child Health Centres asking them to
refer suitable subjects to the participating hospitals. The researcher also visited local
maternal and child health centres around the RWH, talked to lactation consultant
groups, talked to pregnant women in antenatal groups, advertised the study in local
• The inconvenience of travelling to the hospital with a baby three times per
week.
This strongly impacted on mothers participating in the study. Many subjects pointed
out that if they came to the hospital three times per week with their young infant,
they couldn’t keep expressing milk as frequently as the lactation consultant advised.
Subjects in the study also had a problem coming to the hospital to finish all the
The principle supervisor of the study contacted the Victorian Department of Human
Services to seek an exemption from the Skin Penetration Act to allowing the
researcher come to conduct private home treatments of the subjects in order to address
the hospital visit difficulty. Unfortunately the request was rejected by the Department.
The principle supervisor also sought permission from the RWH to allow the
researcher to undertake the study in her nearby clinic. This request has also rejected.
The given reason was that the subjects are patients of the hospital and should only be
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
The researched received many phone calls inquiring about acupuncture for
breastfeeding. Many mothers wanted to go to nearby practitioners rather than take part
in the study, as there was a 50% chance they could be given sham acupuncture. They
didn't want to waste time on the research. Even the mothers who joined the study,
tried very hard to find out which group they were in. One mother asked if she could
bring her friend to look after her baby during treatment. This was a very normal
request. However, the researcher found that the friend was a first year acupuncture
student. One subject brought an acupuncture chart to try to find out if the needling
was on the acupuncture points. One subject watched the TV advertisement about the
study. She found the points used on TV weren't the same as she has received. She
6.2. A course of Traditional Chinese Acupuncture (TCA) for the mother can
Failure to thrive in infants is a most serious problem with the potential to cause
hypernatremic dehydration which can be fatal. Insufficient weight gain can result in a
failure to thrive. The purpose of this study was to see if a course of Traditional
Chinese Acupuncture could increase infant gain and therefore prevent a failure to
thrive.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
This study found that over a two week treatment period, infants in the TCA Group on
average weighed 160.13 grams heavier than their SA Group counterpart. This
increase is about 50% of normal weight gain (normal weight gain is 150gs per week).
The statistics power is marginally significant (p<0.1). Since the significant level is
marginal, we must interpret the effectiveness of the TCA intervention with caution.
At any rate, the study does confirm the existence of a trend, that is, that TCA
The Mother's state of health has often been ignored in terms of its impact on
breastmilk production. Many authors believe that unless the mother has a severe
illness, milk production will not be affected (Lawrence, et al, 1999). In this study, the
researcher observed that the infants of mothers who felt "poor" in their general well
being at the beginning of the study, weighed lighter than the infants of mothers who
felt "good". Wellbeing scales were used to evaluate the overall level of general health
as stated among mothers in both the TCA and SA Groups. There are 5 stages in
evaluating overall health states - excellent, very good, good, fair and poor. In this
study, no participant was feeling excellent. Therefore the five scales became four.
The higher number indicates the worst condition. This study found that a one-unit
increase in the four point wellbeing scale decreases a child’s weight by 107.62 grams
(p<0.01). This finding indicated that mother's health does have a significant impact
Other evidence which confirms that the mother's health state has an impact on breast
milk production is the level of the mother's appetite. In this study, the researcher
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
observed that infants of mothers who had a good appetite weighed heavier than
infants of mothers who had a poor appetite. On a scale of four, one being excessive;
two being good; three being average and four being poor, the study found that other
things being equal, one-unit increase in the 4-point appetite scale (i.e., a tendency of
(p<0.01).
Many herbal medicines have been used anecdotally among breastfeeding mothers to
boost their breast milk production. The commonly used herbs are Milk Thistle and
Fenugreek. In this study the researcher observed that infants of mothers who took the
above herbal medications for enhancing breast milk production at the beginning of the
study weighed heavier than those who mothers didn't. Other things being equal,
children of such mothers weigh 1229.98 grams heavier than those whose mothers do
The literature suggests that the feeling of the breasts being full is not an indication to
the breastmilk production (Lawrence et al1 1999). However, in this study, the
researcher observed that a sense of breast fullness did have a relationship with infant
weight gain. The researcher used a four points scale to determine any relation
between the breast fullness sensation and infant weigh gain. The four points were: the
breast fullness sensation before most feeds (more then 50% of feeds during a day of
24 hours) being 1; full sensation before some feed (less than 50% about more 25% of
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
feeds in a day of 24 hours) being 2 2; full sensation in the breast before feeding
occasionally, normally after a good rest (less than 20% of feeds in a day of 24 hours)
being 3; and never have any full sensation before breastfeed being 4.
The researcher found that infants of mothers who sense the breast as empty most of
the time weigh heavier. Other things being equal, one-unit increase in the 4-point
suggests that infants of such mothers may consume more formula, as the literature
shows that infants consuming formula only, weigh heavier than infants consuming
Disharmony
In this study, the subjects fell into two main disharmony categories: 1) gan (liver) qi
stagnation and 2) pi (spleen) qi or pi qi / xue xu. With those who were experiencing
gan (liver) qi stagnation the following observations were made. Emotional upsets
complaining about something, experiencing lots of frustrations and were often tearful
and overly sensitive. They also experienced quite a bit of breast tenderness.
Whereas with those who were experiencing pi (spleen) qi or / gan xue xu, they mainly
complained about being fatigued and of having a feeling of softness in the breasts
before most feeds. The subjects usually had a longer history of breastfeeding
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
problems or difficulty labour. Some had a history of breast trauma in the past such as
mastitis, nipple pain and tears. Even though the trauma has healed, the subjects often
found that their breasts had become soft most the time. There is also a condition
known in TCM as "high way qi xu” (Lawrence, et al, 1994). Mothers who suffer
from high way qi xu normally have had a history of chronic illness before or during
the pregnancy. These mothers may have insufficient breast tissue. The mother's
breasts may not have changed size during the pregnancy or after birth. Their breasts
are normally soft most of time. In this case, even though the mothers may not have
way qi, the spleen qi cannot carry qi and xue (blood) to the breast to transform into
The study looked at a number of infant variables in relation to infant weight gain.
Gender: This research study observed that boys weigh 737.98 grams heavier than
girls (p<0.01). This finding is consistent with the literature (Lawrence & Lawrence,
1999 p399)
Formula Consumption: This study observed that infants consuming more formula
increases weight by 0.16 grams (p<0.05). This finding is consistent with the literature
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Growth: Older infants grow faster. Other things being equal, a one-day increase in
the age at the beginning of the study increases weight by 20.67 grams (p<0.01).
According to the literature, older infants will slow down in growth (Lawrence &
Lawrence, 1999 p403). However, with an infant who has had a failure to thrive, the
older infant recovers faster in terms of weight gain than a younger infant . Therefore
Infant sucking ability: the infant suckling ability was recorded on a scale of one to
six:
1 being: breastfeed offered - no response, baby did not attach to the breast (baby
2 being: baby interested - but not attached (rooting, mouthing, sucking fists, crying).
3 being: baby attaches - on and off (some mouth/breast contact, not sustained).
4 being: attaches - but uncoordinated suck (low to nil swallowing while sucking).
5 being: nutritive suckling (sucking and swallowing) - short feed, less than 10
minutes.
6 being: nutritive suckling (sucking and swallowing) - long feed, more than 10
minutes (Appendix 7 reference Infant suckling ability tool used in BFAS, RWH ).
However, in this study the infant sucking ability was not significant.
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Infant length and the head circumference: infant length and head circumference was
measured during the two week diary taking phase. However, the information wasn’t
used in the study due to insignificant change over the two weeks period.
Infant average weight gain over the first two weeks: Over the first two weeks (the
treatment phase), infants in both the TCA and the SA Groups generally grew at a rate
of 36.97 grams per day. (p<0.01). This indicated that this study wasn't harmful to the
infant's health.
Unlike the weight model, the linear model of formula change did not fit the data well.
We tested all possible models using the existing predictor variables and found none of
them led to a good fit of the data. This indicates that, the determinants of formula
change are complicated and different from those affecting weight. The model
predictors, that is, time (or rate of change), gender and age. Figure 2 shows that at
most points in time, the model-predicted mean values are not close to the observed
mean values. Evidently, the model only depicts a linear growth trend of formula
change for both groups, and is less robust in capturing the ups-and-downs of the
Given the above finding, the results of the HLM analysis for formula change are only
indicative. The model shows that infants from the TCA Group consume less formula
than their SA Group counterparts. Other things being equal, infants from the TCA
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Group consumed 276.52 millilitres less formula than infants in the SA Group. Since
the model did not fit the data well and important predictors of formula change were
not included in the analysis, any future study using more relevant predictors may
change the results. In summary, the evaluation of the TCA intervention on formula
consumption is inconclusive.
The researcher believes that one of the reasons why the results in this area were
inconclusive was that the formula intake is also altered by the mother's behavior or
how she interprets her infants cry. A mother had written in her feeding diary: "Mat
nurse - 24 hours only breastfeed to see how much breastmilk is available". One
mother had a three month old infant who weighed less then five kilograms at time of
the study. He consumed more the 900ml of formula a day sometime 1200ml of
formula a day. The infant suffered from reflux after being fed. The mother believed
he should have more milk to replace the milk that he had vomited.
Forty-one mothers gave written consent to participate in the study. Twenty of the
mothers chose to participate in the NTC Group. Only twelve in this Group completed
a "two weeks feeding diary." Of the other 12 mothers who hadn't completed the
feeding diary, one mother did not agree that she had IMS and hadn't kept feeding
records. One subject’s infant went into hospital within the two weeks for failing to
thrive. The other nine subjects weaned their infants within two weeks. One subject
mother never responded to the researcher's phone calls. In comparison with the
treatment groups only one subject out of ten in the TCA GROUP withdrew from the
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
study after her first visit. And this was after she received a parking fine while
attending for the initial consultation. Only one, of seven subjects in the SA Group
weaned her infant after the third visit. This might indicate less enthusiasm for
6.10 Follow up
Each month for six months, the researcher telephoned the subjects to ascertain the
status of breastfeeding and the infant’s current weight (weight was measured and
therefore compared on the same scale each time). The infants weight gain stopped
being recorded if the infant had been introduced to solid food within the six months.
The infant was excluded from the study if they had been weaned.
No statistical analysis was applied in the follow up period. This was due to the further
loss of a number of subjects. Many mothers did not weigh their infant monthly after
the two week diary keeping phase. They were more likely to weigh their infant close
to the infant exact age (that is at 3 months, or 4 months) rather than at the dates set by
the study. A few mothers did not respond to the researcher's phone call. It was
interesting that most mothers who did not respond to the researcher's phone calls were
from the gan (liver) qi stagnation group. The mothers who presented with pi (spleen)
qi or pi qi , xue xu weaned their infant earlier due to the breastmilk having "dried up".
There were two subjects out of nine in the TCA Group and two subjects mothers out
of six in the SA Group who weaned their infant by five months. Again the NTC
Group had more mothers having weaned their infants by 5 months. The total number
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Maybe those subjects who had been assessed according to TCM and who were
participating more fully in the trial stayed more enthusiastic about breastfeeding than
1. the low participation rate. 2. because of the low number of subjects, the researcher
hasn't been able to determine the placebo effect in this study. 3. because of the low
numbers of subjects, the researcher was unable to compare the two treatment groups
1. Recruiting subjects from the patients in the neonatal service. Most of the patients
are premature infants. As these infants are very small and most of them have medical
complications, therefore, the normal breastfeeding process has not been established on
time. The mothers rely purely on expressing milk to maintain their milk production.
Most of them take drugs to facilitate breast milk production as well. Even so, many of
them develop IMS later on. There is no other therapy available which can help them,
even including support from lactation consultants. The researcher would only need to
ask the mothers to record the amount of breast milk expressed over a two week
period. The experiment could compare the difference in the quantity of milk
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Group and a Non-Treatment Control Group. By doing this, not only could the
2. providing home visits for the treatment groups and no treatment control group
weighting the infant three time per week and assessing the mother’s health states
(mothers in all three groups) in according with TCM diagnostic principles and then
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Chapter 7. Conclusion
This study found that a course of Traditional Chinese Acupuncture performed on the
nursing mother can increase infant weight gain. It is important to note that all mothers
enough breastmilk from the mother. Failure to thrive in infants is a serious problem
with the potential to cause hypernatremic dehydration which can be fatal. Neither the
mother nor the lactation consultant wants to leave the infant at risk.. Therefore, an
infant who had been diagnosed as failing to thrive will often be introduced to formula
as soon as the diagnosis is made. The introduction of formula often leads to the early
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
*********************************************************************
Main Complaint:
Previous Treatments:
Infant’s Behaviours:
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Infant:
Mother:
History of Labour:
History of Pregnancy
Medical History:
History of Allergies:
Habits: Cigarettes ____; Coffee ____; Tea ____ ; Cola_____ ; Alcohol _____;
Drugs____;
Other________________________________________________________________
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
TCM Examination
Breast:
1. Full sensation, form on breast before every feed.
2. Full sensation, form on breast before most feed.
3. Full sensation, form on breast in before feed occasionally.
4. Never had felt full sensation, breast soft before every feed.
Leaking milk (before feed): No __, Morning: __, Most feed: __, Every feed __.
General feeling:
Energy
0. no difficulty at all for daily activities,
1. a little bit of difficulty,
2. some difficulty,
3. much difficulty
4. could not do
Feeling:
In which word can describe your emotional status
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Reaction of Hot/Cold:
Fevers ; Hot hands ; Hot Feet ; Chills ; Cold Hands ; Cold Feeds ;
Cold Back ; Cold Abdomen .
Sleep:
Heavy ; Well ; Poor ; Broken ; Hard to fall off to sleep ; Dream disturbed ;
Nightmares ; Feeling restless when wake up in morning ;
Week up at night because:
_____________________________Times___________________
Digestive:
Type of Diet:__________
Appetite: 1 Excessive; Good Variable; Poor.
Abdominal Bloating : After Meals At night All time .
Nausea ; Acid reflux ; belching ; Flatulence ; Peculiar Tastes/Smells ______;
Felt thirsty: ; Prefer to drink: Cold/Hot;
Bowel Movement: Frequency ___; Odor__; Texture__ ;
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Urine:
Color__; Odor__; Burning Sensation ; Get up at Night ;__Times;
Lochia / Menstruation:
Body Build:
_______.________._______._______.______
Overweight Normal Slender Skinny
Tongue Examinations:
Shape:
Tongue colour:
Tongue coat
Complexion:
Skin:
Voice:
Respiration:
Pulse:
Left Right
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
Middle
Deep
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A Pilot Study to Evaluate the Effect of Acupuncture on Increasing Milk Supply of Lactating Mothers
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